Post Operative PainNCT05833776
Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia for Knee Arthroscopic Meniscectomy
A study testing spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) in people with Post Operative Pain, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Postoperative analgesia is provided by local anesthesia combined with intrathecal narcotics. In addition, for the first 24 hours, this combination has a parenteral opioid sparing effect. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age from 25 to 60 years old, with ASA physical status I-III undergoing for knee arthroscopy
Who cannot join
- Patient refusal, neuromuscular diseases, allergies to local anesthetics, and contraindications to spinal anesthesia such as coagulopathy and severe mitral stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia on Postoperative Analgesia for Knee Arthroscopic Meniscectomy
Postoperative analgesia is provided by local anesthesia combined with intrathecal narcotics. In addition, for the first 24 hours, this combination has a parenteral opioid sparing effect. However, despite its benefits, this method has been associated to an increased incidence of urine retention, nausea, and vomiting, as well as pruritus. A new localized analgesic approach called as IPACK (infiltration between the knee capsule and the popliteal artery) has been employed in practice.
Read the detailed description
The goal of this study was to compare fentanyl based spinal anesthesia to IPACK Block-based spinal anesthesia during knee arthroscopy.
Patients and Methods: The study enrolled sixty patients with ASA (I-II) ranging in age from 25 to 60 years old after receiving ethical committee permission and written informed consent from patients. They were divided into two groups: group F (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) and group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml). Results: In the first 4 hours postoperatively, there were no variations in VAS scores between the two groups; however, following 4 hours and over the next 12 hours, Group I, VAS scores were lower. The amount of morphine used overall was lower in Group I, which took longer than Group F to reach initial rescue analgesia. The level of patient satisfaction 48 hours after surgery was higher in group I than in group F.
- Conditions
- Post Operative Pain
- Being tested
- spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)
- Keywords
- IPACK Block, spinal anesthesia, Knee arthroscopy.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)Procedure or surgery
group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).
| Study group | Role | What they receive |
|---|---|---|
| group F | Experimental | received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) Receives: Procedure: spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) |
| group I | Experimental | group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml). Receives: Procedure: spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative analgesia
post-operative pain relief
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Jan 2022
- Primary completion1 Feb 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed A Aboelsuod, MD, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833776
- Sponsor's protocol ID
- 91945931
- Status last verified
- Jul 2023
- First submitted
- 5 Apr 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia on Postoperative Analgesia for Knee Arthroscopic Meniscectomy
- ClinicalTrials.gov ID
- NCT05833776
- Acronym / sponsor ID
- 91945931
- Conditions
- Post Operative Pain
- Keywords
- IPACK Block, spinal anesthesia, Knee arthroscopy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative analgesia is provided by local anesthesia combined with intrathecal narcotics. In addition, for the first 24 hours, this combination has a parenteral opioid sparing effect. However, despite its benefits, this method has been associated to an increased incidence of urine retention, nausea, and vomiting, as well as pruritus. A new localized analgesic approach called as IPACK (infiltration between the knee capsule and the popliteal artery) has been employed in practice.
Detailed description
The goal of this study was to compare fentanyl based spinal anesthesia to IPACK Block-based spinal anesthesia during knee arthroscopy.
Patients and Methods: The study enrolled sixty patients with ASA (I-II) ranging in age from 25 to 60 years old after receiving ethical committee permission and written informed consent from patients. They were divided into two groups: group F (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) and group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml). Results: In the first 4 hours postoperatively, there were no variations in VAS scores between the two groups; however, following 4 hours and over the next 12 hours, Group I, VAS scores were lower. The amount of morphine used overall was lower in Group I, which took longer than Group F to reach initial rescue analgesia. The level of patient satisfaction 48 hours after surgery was higher in group I than in group F.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group F | Experimental | Procedure: spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) |
| group I | Experimental | Procedure: spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml). |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age from 25 to 60 years old, with ASA physical status I-III undergoing for knee arthroscopy
Key exclusion criteria (1 listed)
- Patient refusal, neuromuscular diseases, allergies to local anesthetics, and contraindications to spinal anesthesia such as coagulopathy and severe mitral stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml). | Procedure or surgery | group F, group I |
Primary outcome
post-operative analgesia
Time frame: 24 hours
post-operative pain relief
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) in people with Post Operative Pain, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative analgesia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.